Job Description - Senior Regulatory Affairs Associate - Johnson & Johnson MedTech (2406226409W)
Johnson & Johnson MedTech is currently seeking a Senior Regulatory Affairs Associate.
Location: Leeds Office, (hybrid model, 3 days in office 2 at home)
The Regulatory Affairs Senior Associate will execute regulatory activities to support currently marketed devices and new product development in the Johnson & Johnson MedTech | Orthopaedics Joint Reconstruction line of products. This role involves a multi-faceted set of skills including sound regulatory judgment, cross-functional collaboration, and planning/oversight/execution of projects and activities that directly impact the operational results of the business.
What you will be Doing:
In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
1. Provide full support to all registration activities, CE marking and regulatory submissions throughout the world.
2. Facilitate worldwide product registration activities by compiling appropriate dossiers, submissions and responses to regulatory bodies.
3. Establish and maintain processes for submissions, interim notifications and periodic resubmissions.
4. In conjunction with other departments, ensure that the company's post marketing surveillance responsibilities are fulfilled and support vigilance activities.
5. Maintain information on worldwide regulatory requirements and the status of product registrations.
6. Liaise with all departments and project teams to co-ordinate timely applications for CE marking and other approvals.
7. Provide support and advice to company colleagues, particularly product development, concerning CE marking and other world regulatory requirements.
8. To maintain progress and developments of worldwide regulatory environments, and to address regulatory requirements as appropriate.
9. To follow and promote Company, HS&E and Quality procedures and standards to enable the site to achieve and maintain excellent results.
10. To carry out such further tasks that may be delegated to me by my immediate manager.
11. Responsible for communicating business related issues or opportunities to next management level.
12. Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
13. Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
14. Performs other duties assigned as needed.
What you will bring:
* A degree in a relevant scientific discipline and/or significant area of expertise developed through experience and positive track record.
* Significant regulatory experience covering medical devices and/or pharmaceuticals.
* Commanding knowledge of worldwide regulatory procedures, especially for medical devices.
* Able to demonstrate proven track records of achievements.
* Able to demonstrate projects undertaken have been satisfactorily completed within agreed timescales.
* Possess computer competency in Microsoft office software, data collection and general analysis tools.
* Communication – listener, learner and thinker.
* Product awareness and thorough knowledge of respective regulatory frameworks.
* Demonstrated expertise in medical device regulatory requirements and processes.
* Excellent project management skills by demonstrated competence in managing multiple projects simultaneously.
* Capable of providing direction and training to junior colleagues.
* Experience in worldwide regulatory systems.
Other considerations:
* Reports directly to the Regulatory Affairs Manager/ Assistant Director / Director, and co-ordinates with the other Regulatory Affairs Associates. Liaise with personnel in all departments.
* Co-ordinate registrations with external regulatory bodies, distributors and subsidiaries.
* UK, France, US – Flexible or remote working arrangements may apply.
* Domestic and international travel may be occasionally required.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
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